Infusion catheter

ABSTRACT

A catheter for use with a medical infusion or other fluid system. The catheter may include a flexible elongate tubular core that is resistant to radial collapse. The catheter may further include a flexible, e.g., elastomeric, jacket that surrounds at least a portion of the tubular core. The jacket may have a radial compliance that is greater than that of the tubular core. The jacket may further define an outer diameter that is about 4 to about 6 times greater than an outer diameter of the core.

RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 11/589,694, filed Oct. 30, 2006, and is also acontinuation-in-part of U.S. patent application Ser. No. 11/589,697,also filed Oct. 30, 2006, both of which are incorporated herein byreference in their respective entireties.

TECHNICAL FIELD

The present invention relates generally to medical devices and, moreparticularly, to catheters, portal anchors, catheter connectors, andsystems for delivering a therapeutic agent to a region of a body such asthe brain.

BACKGROUND

Medical procedures involving the delivery or removal of fluids from thebody often utilize a catheter system for fluid transport. The cathetersystem may include a flexible tube or catheter that operatively entersthe body, and an externally located fluid reservoir. One example of aremoval catheter system is a urinary catheter for use with patients thatmay have difficulty urinating.

Other catheter systems are capable of delivering a fluid, e.g., atherapeutic agent, to the body. For example, the use ofintracerebroventricular or parenchymal catheters is known for infusingtherapeutic agents to a specific location within the brain to treat avariety of disorders including, for example, chronic pain and movementdisorders. In an illustrative example, an incision is made in apatient's scalp to expose the skull through which a burr hole may thenbe formed. The catheter may then be inserted through the burr hole andanchored in place, e.g., with a burr hole anchor. Surgeons may often usestereotactic apparatus/procedures to position implanted catheters andother brain instruments (e.g., electrical stimulation leads). Forexample, U.S. Pat. No. 4,350,159 to Gouda illustrates an exemplarystereotactic instrument used to position an electrode.

As one can appreciate, once an inserted device such as a catheter isproperly positioned, it is important that it be adequately immobilizedto prevent movement from its intended location. Even minimal movement ofthe device tip may yield unsatisfactory therapeutic results.Accordingly, reliable methods and apparatus for anchoring and securingthe device relative to the burr hole are needed. To secure the catheterrelative to the burr hole, burr hole anchor devices, including devicessimilar to those described in U.S. Pat. No. 4,328,813 to Ray and U.S.Pat. No. 5,927,277 to Baudino et al., may be used.

Many of these anchor devices are used primarily to secure a catheter orlead for long term implantation. Some therapies (e.g., acute genetherapy for the treatment of Parkinson's disease, chemotherapy),however, may be delivered during a more limited period of time, e.g., afew hours to a few days or less. In the case of the latter, it may bebeneficial to completely remove the delivery catheter at therapycompletion. Device (e.g., catheter) removal, though, generally requiresa surgical procedure to: expose the burr hole and anchor; release thecatheter from the anchor; remove the catheter; and close the incision.While effective, such a removal procedure may be undesirable for variousreasons, including, for example, cost and potential patient apprehensionassociated with the surgical removal procedure.

The portion of the catheter extending beyond the skull may be tunneledbeneath the skin (e.g., to connect to an implanted reservoir or pump)or, alternatively, routed outside the body where it may connect,typically via a longer secondary tube, to an external source containingthe therapeutic agent.

While fully implanted systems may be beneficial for long term treatmentof certain chronic ailments, external routing may be preferable forshorter term therapies (e.g., those lasting a few days or less). Currentexternal routing configurations may, however, present issues notnecessarily present with internal systems. For example, the externalizedcomponents may benefit from various attachment and strain relieftechniques to minimize movement of the implanted catheter that mightresult from exposure to inadvertent, external forces. Moreover, in theevent of a catheter break, the externalized catheter system may requirecomponent replacement and/or additional sterilization procedures inorder to reduce potential contamination. While such attachmenttechniques and sterilization procedures are effective, it may bebeneficial if the need for such additional measures could be reduced oreliminated.

Short term therapies may further benefit from catheters that are of anadvantageous size (e.g., diameter) for the particular therapy deliveryprofile. For example, many conventional catheters are of a diameter thatis unnecessarily large for shorter term, low volume therapy delivery.However, conventional catheters having a small diameter may be subjectto inadvertent occlusion as a result of anchoring or twisting of thecatheter.

SUMMARY

Catheters, anchors, connectors, and systems in accordance withembodiments of the present invention may overcome these and otherissues. For instance, in one embodiment, an implantable catheter isprovided for delivering a therapeutic agent to a body. The catheterincludes an elongate tubular core having a distal end and a proximalend, wherein the core defines a lumen extending between the distal andproximal ends. The core includes a material selected from the groupconsisting of silica, quartz, and polyetheretherketone (PEEK). Thecatheter also includes an elastomeric jacket surrounding and secured toan outer surface of the tubular core, the elastomeric jacket having aradial compliance greater than a radial compliance of the tubular core.An outer diameter of the elastomeric jacket is about 4 or more timeslarger than an outer diameter of the tubular core.

In another embodiment, an implantable catheter for delivering atherapeutic agent to a body is provided, wherein the catheter has anelongate tubular core including fused silica. The tubular core includesa distal end, a proximal end, and a tubular body forming a lumenspanning between the distal and proximal ends. An elastomeric jacketincluding polyurethane is also provided, the jacket surrounding andsecured to an outer surface of the tubular core. An outer diameter ofthe elastomeric jacket is about 4 to about 6 times greater than an outerdiameter of the tubular core.

The above summary is not intended to describe each embodiment or everyimplementation of the present invention. Rather, a more completeunderstanding of the invention will become apparent and appreciated byreference to the following Detailed Description of Exemplary Embodimentsand claims in view of the accompanying figures of the drawing.

BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWING

The present invention will be further described with reference to thefigures of the drawing, wherein:

FIGS. 1A-1B illustrate an exemplary system, e.g., infusion system,including a connector (e.g., breakaway connector), infusion catheter,and portal anchor in accordance with one embodiment of the invention,wherein: FIG. 1A is a diagrammatic view of the system implanted in ahuman body; and FIG. 1B is a view of the system removed from the body;

FIGS. 2A-2B illustrate enlarged perspective views of the exemplaryconnector of FIGS. 1A-1B, wherein: FIG. 2A is an enlarged perspectiveview of the connector; and FIG. 2B is an exploded perspective viewillustrating how a modified connector may be attached to a headgearapparatus;

FIG. 3 is a section view of the connector of FIG. 2A, taken through aplane containing a longitudinal axis of the connector, illustrating botha first coupler and a second coupler;

FIG. 4 illustrates the section of the connector shown in FIG. 3 with thefirst coupler shown separated from the second coupler;

FIGS. 5A-5B illustrate an exemplary retention device, e.g., a rollerassembly, for use with the connector of FIG. 2A, wherein: FIG. 5A is anenlarged perspective view of the roller assembly; and FIG. 5B is asection view taken along line 5B-5B of FIG. 2A;

FIG. 6 is an exploded perspective view of the first coupler of theconnector of FIG. 2A;

FIGS. 7A-7C illustrate various aspects of the first coupler of FIG. 2A,wherein: FIG. 7A is a section view of the first coupler in a partiallyassembled state, the view taken through a plane containing alongitudinal axis of the first coupler; FIG. 7B is a perspective view ofa stop member of the first coupler; and FIG. 7C is a partial perspectivesection view of a portion of the first coupler;

FIGS. 8A-8B illustrate a retention device in accordance with anotherembodiment of the invention, wherein: FIG. 8A is an exploded partialperspective view; and FIG. 8B is a perspective section view;

FIGS. 9A-9B illustrate a catheter in accordance with one embodiment ofthe invention, wherein FIG. 9A illustrates a side elevation view; andFIG. 9B illustrates a section view taken along line 9B-9B of FIG. 9A;

FIGS. 10A-10E illustrate a catheter in accordance with anotherembodiment of the invention, wherein FIG. 10A illustrates a breakawayside elevation view; FIG. 10B illustrates an enlarged breakaway view ofa portion of the catheter; FIG. 10C illustrates a section view takenalong line 10C-10C of FIG. 10A; FIG. 10D illustrates an enlarged sectionview of a distal end portion of the catheter; and FIG. 10E is a sideelevation view;

FIGS. 11A-11E illustrate a catheter in accordance with anotherembodiment of the invention, wherein FIG. 11A illustrates a breakawayside elevation view; FIG. 11B illustrates an enlarged breakaway view ofa first portion of the catheter; FIG. 11C illustrates an enlargedbreakaway view of a second portion of the catheter; FIG. 11D is asection view taken along line 11D-11D of FIG. 11A; and FIG. 11E issection view taken along line 11E-11E of FIG. 11B;

FIG. 12 is a perspective view of the exemplary anchor assembly, e.g.,burr hole anchor, of FIGS. 1A-1B with a base of the anchor shownattached to the body, e.g., skull, and a retainer of the anchor shownbefore attachment to the base;

FIG. 13 is a cross section of the anchor assembly of FIGS. 1A-1B as itmay be implanted within the body;

FIG. 14 is an exploded perspective view of the anchor assembly of FIGS.1A-1B;

FIG. 15 is a partial cut-away view of the anchor of FIGS. 1A-1B, whereinthe retainer is shown in a first or unlocked configuration correspondingto an arm of the retainer being in a first or unlocked position, andfurther wherein a latch of the retainer is shown in a first or unlatchedposition;

FIG. 16 is a perspective view of the anchor assembly of FIGS. 1A-1B withthe retainer shown in a second or locked configuration corresponding tothe arm being in a second or locked position, and the latch of theretainer shown in a second or latched position;

FIG. 17 is a top plan view of the anchor assembly of FIG. 15 with thearm shown in the unlocked position, but with the latch shown in thelatched position;

FIG. 18 is a top plan view of the anchor assembly of FIG. 16 with thearm shown in the locked position and the latch shown in the latchedposition;

FIGS. 19A-19B illustrate section views of the anchor assembly of FIG.17, wherein: FIG. 19A is a section view taken along line 19A-19A of FIG.17 but with the latch of the retainer shown in the unlatched position;and FIG. 19B is a section view similar to that of FIG. 19A, but with thelatch of the retainer shown in the latched position;

FIG. 20 is a bottom plan view of the anchor assembly of FIG. 17 with thelatch shown in the latched position and the arm shown in the unlockedposition;

FIGS. 21A-21D illustrate an exemplary method for using the anchorassembly of FIGS. 1A-1B, wherein: FIG. 21A illustrates attachment of theanchor base to the skull; FIG. 21B illustrates insertion of the anchorretainer into the anchor base; FIG. 21C illustrates external portions ofthe anchor assembly and catheter after an implantation incision isclosed; and FIG. 21D illustrates unlocking and removal of the catheterat therapy completion;

FIGS. 22A-22B illustrate an anchor assembly in accordance with analternative embodiment of the invention, wherein: FIG. 22A is aperspective view of the anchor assembly during assembly of an anchorretainer with an anchor base; and FIG. 22B illustrates the anchorassembly after assembly and with the retainer shown in a first orunlocked configuration corresponding to an arm of the retainer being ina first or unlocked position;

FIG. 23 is a perspective view of the anchor assembly of FIGS. 22A-22Bwith the retainer shown in a second or locked configurationcorresponding to the arm being in a second or locked position;

FIGS. 24A-24B illustrate an optional cap for use with the anchorassembly of FIGS. 22A-22B, wherein: FIG. 24A is a bottom perspectiveview prior to attachment of the cap; and FIG. 24B is a top perspectiveview after attachment of the cap; and

FIGS. 25A-25D illustrate an anchor assembly in accordance with yetanother embodiment of the invention, wherein: FIG. 25A is a perspectiveview of the anchor assembly during attachment of an anchor retainer withan anchor base; FIG. 25B illustrates immobilization of the catheter;FIG. 25C illustrates release of the catheter, e.g., at therapycompletion; and FIG. 25D illustrates a bottom perspective view of theanchor retainer of FIGS. 25A-25C.

The figures are rendered primarily for clarity and, as a result, are notnecessarily drawn to scale.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

In the following detailed description of illustrative embodiments of theinvention, reference is made to the accompanying figures of the drawingwhich form a part hereof, and in which are shown, by way ofillustration, specific embodiments in which the invention may bepracticed. It is to be understood that other embodiments may be utilizedand structural changes may be made without departing from the scope ofthe invention.

Embodiments of the present invention are directed generally to fluidcoupling devices, fluid conduits, anchoring devices, and to systems andmethods incorporating the same. For example, embodiments of theinvention may include: medical connectors for coupling a first tube(e.g., catheter) to a second tube; corresponding tubes and catheters;and body portal anchors for securing therapy delivery devices (such astubes/catheters) relative to a body portal. Other embodiments of theinvention may be directed to implantable medical systems, e.g., infusionsystems (incorporating one or more of these components), for infusing atherapeutic agent into a body.

FIGS. 1A and 1B illustrate an exemplary implantable medical system(e.g., a brain infusion catheter system 100) in accordance with oneembodiment of the invention. FIG. 1A illustrates the system as it may beconfigured during use, e.g., implantation, while FIG. 1B illustrates thesystem removed from the body.

The exemplary infusion system may include a first medical tube, e.g.,brain catheter 108, and a second medical tube, e.g., secondary tube 102.The tube 102 may have its distal end 104 coupled to a reservoir (e.g.,infusion pump 106, which may be identical or similar in construction toinsulin pumps such as the Paradigm 515 or 715 pumps produced byMedtronic MiniMed of Northridge, Calif., USA) containing a volume of atherapeutic agent. Similarly, the brain catheter 108 may have its distalend 110 implanted within the body 101 (as used herein, the terms“distal” and “proximal” are taken from the reference of a connector 200as shown in FIG. 1). In the illustrated example, the catheter 108 hasits distal end 110 implanted, via a burr hole 112, at a predeterminedlocation within a brain 114 of the patient. A burr hole anchor 1200 maybe used to secure the catheter 108 relative to the burr hole 112. Theanchor 1200 may form part of an anchor assembly 1201 that may alsoinclude a lock member 1208 described in more detail elsewhere herein. Aproximal end 116 of the catheter 108 may extend outside the body 101 andconnect to a corresponding proximal end 118 of the tube 102, e.g., viathe connector 200.

While described herein in the context of a pump 106, this configurationis not limiting. For example, other embodiments may replace the pumpwith most any medicament delivery device, e.g., syringe, drip bag, etc.,without departing from the scope of the invention.

The system 100 may, in one embodiment, be configured to deliver atherapeutic agent containing a virally mediated gene therapy as an acutetreatment for Parkinson's disease. The therapeutic agent is delivered,via the tube 102 and catheter 108, from the pump 106 to the brain 114.This application is not limiting, however, as the system may beconfigured to deliver most any therapeutic agent (e.g., chemotherapy) tomost any area of the body without departing from the scope of theinvention.

It is noted that the terms “comprises” and variations thereof do nothave a limiting meaning where these terms appear in the accompanyingdescription and claims. Moreover, “a,” “an,” “the,” “at least one,” and“one or more” are used interchangeably herein.

Relative terms such as left, right, forward, rearward, top, bottom,side, upper, lower, horizontal, vertical, and the like may be usedherein and, if so, are from the perspective observed in the particularfigure. These terms are used only to simplify the description, however,and not to limit the scope of the invention in any way.

With this general overview, the following description will addressvarious embodiments of the system 100 and its components, and methodsfor making and using the same. While these embodiments may be describedwith some degree of specificity, they are nonetheless intended to beexemplary. Those of skill in the art will recognize that otherembodiments are possible without departing from the scope of theinvention.

It is further noted that the following description is organized byheadings and subheadings for organizational purposes only. Accordingly,the particular headings/subheadings are not intended to limit in any waythe embodiments described therein, i.e., alternative embodiments of acomponent presented under one heading or subheading of the specificationmay be found elsewhere (e.g., under another heading) in thespecification. As a result, the specification is intended to beconsidered in its entirety.

Connectors

One aspect of the present invention is directed generally to fluidcoupling devices and, in particular, to medical connectors such asconnector 200 shown in FIGS. 1A and 1B, systems, and to methods forcoupling a first tube (e.g., catheter) to a second tube or other medicaldevice. In the illustrated embodiment, the connector is shown as part ofthe catheter, e.g., infusion, system 100 having the partially implantedcatheter 108 and the external infusion pump 106. However, thisconfiguration is not limiting as embodiments of the connectors,connector systems, and other aspects of the present invention may finduse in other catheter applications, as well as in other medical andnon-medical fluid systems.

Connectors in accordance with embodiments of the present invention maybe configured to separate or de-couple once a threshold traction forceis applied across the connector (e.g., applied to the two tubes 102, 108joined by the connector). As a result, the connector provides a“breakaway” function in the event of exposure to inadvertent forces.Preferably, two couplers of the connector engage one another via a lowfriction (e.g., substantially functionless) retention device. In theembodiments described and illustrated herein, the connector may alsomaintain a closed fluid path, in the event of connector breakaway, toprotect the implanted catheter from contamination.

An enlarged view of the exemplary connector 200 is illustrated in FIG.2A. The connector 200 may include a second connector portion or coupler202 attached to the secondary tube 102 and a first connector portion orcoupler 204 attached to the brain catheter 108 as further describedbelow (see also FIG. 11B). In the illustrated embodiment, the firstcoupler 204 may be supported by an optional headgear apparatus 120 (seeFIG. 1A), which may hold the connector 200, e.g., via a connection withthe first coupler, during implantation. While illustrated as supportedby a headgear apparatus 120 in FIG. 1A, the connector 200 couldalternatively be generally unsupported, e.g., supported only by the freeproximal ends 116 and 118 of the catheter 108 and tube 102,respectively, without departing from the scope of the invention.

As further illustrated in FIG. 1A, the catheter 108 may be supported atthe body by the body portal anchor, e.g., burr hole anchor 1200.Exemplary burr hole anchors are described in more detail below and inrelated U.S. patent application Ser. No. 11/589,697, filed on Oct. 30,2006.

FIG. 2B illustrates one exemplary embodiment for attaching the connector200 to the headgear apparatus 120. The headgear apparatus may be formedfrom a series of adjustable, fabric (e.g., nylon webbing) or elasticbands (only two bands 120a and 120b are illustrated in FIG. 2B). Thebands may surround the head of the patient, as shown in FIG. 1A,sufficiently to reduce or even prevent the headgear apparatus 120 fromsubstantial movement relative to the patient's head. On one or moresides, the headgear apparatus 120 may have attached thereto (e.g.,riveted) a circular snap fit receptacle 122 that, in one embodiment, issimilar or identical to the female portion of a conventional metallicgarment snap button.

The first coupler 204 of the connector 200 may optionally include anintegrally formed (or otherwise attached) bracket that forms a receivingslot 207 (shown only in FIG. 2B) along one side. The receiving slot 207may be configured to receive a tab 126 of a clip 128. Once the tab 126is fully inserted into the slot 207, the clip 128 may be generallyattached to the connector 200 until the components are intentionallydisassembled. The clip may also include a male member 130 that isreceivable by the snap fit receptacle 122 (the male member 130 may besimilar or identical in construction to a male portion of theconventional garment snap button). Once the clip is attached to thereceptacle 122, the clip (and thus the connector 200) may pivotgenerally about an axis of the receptacle, e.g., providing some degreeof stress relief to the catheter 108.

FIG. 3 is a cross sectional view of the connector 200 of FIG. 2A (takenthrough a plane containing a longitudinal axis of the connector) withthe couplers 202 and 204 connected. FIG. 4, on the other hand, is asimilar section view with the couplers detached. Each of the couplers202 and 204 is described separately below with reference to thesefigures.

The second coupler 202 may form a tubular body 205 defining a bore 206.The body 205 may be made from various materials including, for example,polyetheretherketone (PEEK), polycarbonate, and similar materials. Ahollow needle 208 may be attached to the body 205 and extend into thebore 206 as illustrated. The needle 208 may define a lumen or passagewayin fluid communication with the tube 102. The needle 208 may be affixedto the body 205 via any acceptable technique including, for example, byadhesive.

The body 205 also defines a smaller secondary bore 210 configured toreceive the tube 102. The tube 102 may attach to the second coupler in amanner similar to the needle 208, e.g., with adhesive. When assembled asillustrated in FIGS. 3 and 4, fluid may travel from the source (e.g.,pump 106 of FIGS. 1A-1B) through a lumen of the tube 102 and through thehollow needle 208.

The connector 200 may further include a retention device, e.g., biasedretention device 300, which, in the illustrated embodiment, is attachedto, or otherwise associated with, the second coupler 202. The retentiondevice 300, further illustrated in FIGS. 5A and 5B (some structureremoved for clarity in these views), may include a roller assembly 301having an axle 302 and a cylindrical roller 304 rotatable about theaxle. A tension member, e.g., spring 306, may also be included andattached to opposite first and second ends of the axle 302. The spring306 may extend circumferentially about the tubular body 205 of thesecond coupler 202 as shown.

The roller assembly, e.g., the cylindrical roller 304, may, in a firstconfiguration, be positioned offset from (and preferably transverse to),an axis 214 of the first and second couplers. The axle 302 may beconfigured to move (e.g., translate) within slots 212 formed in the body205 such that the axle and roller 304 are movable primarily in a radialdirection 308 (see FIGS. 4, 5A, and 5B) from the axis 214 (see FIG. 4)of the couplers. The spring 306, which may be a conventional (e.g.,stainless steel) extension spring, may provide a radially-biased forceto the axle 302 that tends to pull the roller assembly 301 (e.g., theaxle 302 and roller 304), towards the axis 214. The other components ofthe roller assembly, e.g., the roller 304 and the axle 302 may also bemade from stainless steel or other materials as described below.

The roller assembly 301 may further include a washer or flange 310. Theflange 3 10, which may be integrally formed with the axle 302, assistswith guiding the roller assembly 301 within the slots 212 as shown inFIGS. 5A and 5B.

As illustrated in FIG. 5B, the roller assembly 301 of the retentiondevice may also include a contact surface 312 (e.g., the outer surfaceof the roller 304). The contact surface 312 may, in the illustratedembodiment, form a secant 311 extending through the bore 206 of thetubular body 205 when the roller assembly is in the first configurationshown in solid lines in FIG. 5B (e.g., corresponding to a groovedsurface 226 of the first coupler 204 (see FIG. 4) being aligned with theroller 304). As further described below, the roller assembly 301, e.g.,the roller 304 and contact surface 312, may move to a secondconfiguration (shown in broken lines in FIG. 5B), wherein the contactsurface 312 is located at or outside of the bore 206. Thus, as furtherdescribed below, the roller assembly 301 may be configured toselectively interlock the second coupler 202 with the first coupler 204;and release the first coupler from the second coupler when apredetermined traction force is applied between the first and secondcouplers.

The second coupler 202 may further include an optional sleeve 216 thatcovers at least a portion of the outer surface of the body 205. Thesleeve 216 may reduce the potential for patient/clinician contact withportions of the retention device 300, and may further prevent foreignobjects from interfering with its operation. Exemplary materials for thesleeve include polyurethane and polypropylene. The sleeve 216 mayinclude a lip (e.g., a discontinuous lip as shown in FIGS. 3 and 4) orother locating feature that permits it to snap or bias into placerelative to the body 205.

The first coupler 204 is illustrated in detail in FIGS. 3, 4, 6, and7A-7C. The first coupler may, in the illustrated embodiment, be formedby an attachment member 218 and a housing 220, both of which may beconstructed from materials similar to the body 205 of the second coupler202.

The attachment member 218 may include an engagement portion 219receivable within the bore 206 of the second coupler 202. The attachmentmember 218 may also include a body portion 217 that is threadablyengagable with the housing 220. In the illustrated embodiment, theattachment member 218 is, when inserted into the bore 206, coaxial withthe second coupler 202.

The engagement portion 219 may include an outer surface 222 having agenerally cylindrical cross section. The roller 304 of the rollerassembly 301 may be configured to engage the outer surface 222 of theengagement portion 219 in rolling contact as the engagement portionmoves, e.g., translates, within the bore 206 of the second coupler 202.The outer surface 222 may be formed by both an engagement surface 224defined by a first diameter, and the grooved surface 226 (or “groove”)defined by a second diameter that is less than the first diameter (see,e.g., FIG. 4). The grooved surface 226 is positioned along theengagement surface 224 so as to receive the roller assembly 301 of theretention device (e.g., the roller 304) when the first coupler 204 isfully engaged with the second coupler 202 as shown in FIG. 3. Thephrases “fully engaged,” “fully connected,” “fully inserted,” and thelike are used herein to indicate that the noted components are engagedto a point where further engagement is either not possible or notnecessary to the proper functioning of the connector.

The outer surface 222 may further include a ramped surface 228 extendingbetween the grooved surface 226 to the engagement surface 224. Theramped surface 228 may act as a camming surface to permit rollingcontact of the roller 304 back and forth between the engagement surface224 and the grooved surface 226.

The attachment member 218 may form a tubular wall that defines apassageway 221 extending through the attachment member. The passageway221 may surround or otherwise contain a needle-penetrable septum 230 inthe vicinity of the engagement portion 219. The septum 230 may be madeof most any material that permits selective penetration by the needle208 and self-sealing upon needle withdrawal. While other materials arepossible, the septum 230 is, in one embodiment, made of silicone.

The septum 230 may be secured within the passageway 221 in most anyfashion. For example, in the illustrated embodiment, the passageway 221may form a step surface 232 (e.g., proximate the engagement portion 219)against which the septum 230 may be located. A retaining member 234 maythen be secured (e.g., via adhesive or the like) within the passageway221 to secure the septum 230 in place. The retaining member 234 may, inone embodiment, have a tapered interior surface 236 that assists inguiding the needle 208 into the septum 230 as the first coupler 204 isconnected to the second coupler 202.

The attachment member 218 may be attached to the housing 220 before useas further described below. While the particular attachment techniquemay vary without departing from the scope of the invention, the bodyportion 217 of the attachment member may, in the illustrated embodiment,include a threaded portion (e.g., male thread 260) operable to engage acorresponding threaded portion (e.g., female thread 258) of the housing220 as shown in FIGS. 3, 4, 6, and 7A.

As evident in the figures, the body portion 217 may be of largerdiameter that the engagement portion 219 to accommodate variouscomponents of the first coupler 204. For example, the body portion 217may be sized to receive a seal 238 within the passageway 221. The seal238 preferably includes a lumen that extends completely through theseal. The lumen of the seal may be configured to receive the proximalend 116 of the catheter 108 and form a substantially leak-free sealtherewith. In one embodiment, the seal 238 may include a generallycompliant body (e.g., made from silicone or similar material) configuredto surround the end 116 of the catheter 108, and an optional rigidtubular member 240 positioned within the lumen, e.g., proximate one endof the compliant body. The rigid tubular member 240 may serve variouspurposes including, for example, preventing Occlusion of the lumen ofthe seal 238 as the seal is compressed. Moreover, the member 240 mayprovide an abutting surface against which the proximal end 116 of thecatheter 108 may seat during assembly of the first coupler 204.

The tubular member 240 may be made from most any material that can holdits shape as the seal 238 is compressed. Exemplary materials includepolysulfone and polycarbonate. The tubular member 240 may be attached tothe body of the seal (e.g., adhesive, interference fit), or it may beheld in place merely by contact between the inner surface of thepassageway 221 and a step surface formed in the seal body.

FIG. 6 provides an exploded view of the first coupler 204. As shown inthis view, the seal 238 may include a tapered surface 242 to seatagainst a corresponding tapered surface within the passageway 221 of theattachment member 218 as shown in FIGS. 3 and 4. The first coupler 204may also include a collet 244 located within the passageway 221 of theattachment member 218. The collet 244 is configured to, in conjunctionwith the housing 220, compress the seal 238 and clamp or otherwiseimmobilize the catheter 108. The collet 244 may include a piston 246that abuts the seal 238, and a split rod 248 operable to receive thecatheter 108 therein. The collet 244 may further include a colletpassageway 250, extending through the collet (e.g., through the piston246 and split rod 248), through which the catheter 108 may pass as shownin FIGS. 3 and 4. The collet 244 may be made from a material similar tothat of the body 205.

As further described below, the collet 244 may translate within theattachment member 218. To limit the range of travel of the collet, astop or stop member 252 may be provided. FIG. 6 illustrates that thestop member 252 may include ears 254 (only one shown) configured toengage openings 256 (only one shown) in the body portion 217 of theattachment member 218. Once the ears 254 are engaged with the openings256, the stop member 252 generally limits travel and prevents removal ofthe collet 244 from the attachment member 218 (unless the stop member isfirst removed).

As with the other components of the first coupler 204, the housing 220may define a passageway 262 extending completely through the componentto permit passage of the catheter 108. At the outermost end of thehousing 220, e.g., where the catheter exits, the passageway 262 mayflare to form a bell-mouth opening 264. The large radius of thebell-mouth opening 264 may reduce strain on the catheter 108 during theimplantation period.

The portion of the passageway 262 opposite the bell-mouth opening 264may form a frusto-conical surface 266 diverging towards the piston 246of the collet 244 as shown in FIGS. 3 and 4. The frusto-conical surface266 is configured to contact two or more movable (e.g., deflectable)legs 268 of the split rod 248 of the collet as the housing 220 isthreaded onto the attachment member 218. As the surface 266 contacts thelegs 268, the legs may be directed inwardly towards the catheter 108.The legs 268 may mechanically (e.g., frictionally or via a biting orclamping action) engage the catheter 108 when the housing 220 is fullyengaged with the attachment member 218 as described below. In theillustrated embodiment, the legs 268 may include protrusions 270 (seeFIG. 7C) to assist with engagement of the catheter 108.

The frusto-conical surface 266 of the housing may also terminate at anabutting surface configured to contact and push against the piston 246of the collet 244. As a result, when the housing 220 is fully engagedwith, e.g., threaded onto, the attachment member 218, the collet 244 mayboth compress the seal 238 against an inner surface of the attachmentmember, and mechanically engage the catheter 108.

FIGS. 6 and 7A-7C illustrate assembly of the first coupler 204. As shownin these views, the septum 230 and retaining member 234 may be securedwithin the passageway 221 of the attachment member 218 as discussedabove. The seal 238, collet 244, and stop member 252 may then be placedinto the attachment member 218 and the stop member positioned such thatthe ears 254 engage the openings 256 as described above. To assist withaligning the stop member 252 with the openings 256, grooves 253 may beprovided along the inside surface of the attachment member 218 as shownin FIG. 7C.

Once the seal 238 and collet 244 are positioned, the housing 220 may beplaced over the attachment member 218 as shown in FIG. 7A. When thehousing 220 is sufficiently engaged with the attachment member 218,optional tabs 271 may be inserted and secured within openings 272 (onlyone opening shown in FIG. 6). The tabs 271 may protrude past theinterior surface of the housing 220 such that, when the housing isunthreaded and withdrawn from the attachment member 218, the tabs engagea raised lip 274 of the attachment member to prevent inadvertentcomponent separation. The tabs 271 may secure to the housing 220 viamost any acceptable method including, for example, adhesive or pressfit.

As illustrated in the figures, see, e.g., FIG. 7C, the collet 244 mayinclude clocking features (e.g., one or more keys 276 located on theouter surface of the piston 246) that engage the attachment member 218(engage either or both of the keyways 253 and keyways 278 formed on theinner surface) and prevent relative rotation. The external surface ofthe attachment member 218 may also include one or more keys 280 (seeFIG. 6) that engage corresponding keyways (visible in FIG. 4) on aninner surface of the second coupler 202 to prevent relative rotation ofthe couplers 202 and 204 during use.

At this point, the catheter 108 may be inserted into the first coupler204, via the bell-mouth opening 264, until it bottoms out in the seal238 (e.g., contacts the tubular member 240) as shown in FIG. 7A. Thecatheter 108 may include markings, e.g., laser markings (furtherdescribed below), that assist the clinician in determining if thecatheter is fully inserted. The housing 220 may then be moved until thefemale thread 258 engages the male thread 260 of the attachment member218. Subsequent threading of the housing 220 onto the attachment member218 results in compression of the seal 238, thereby sealing the fluidpath between the first coupler 204 and the catheter 108.

Moreover, relative movement between the housing and attachment memberresults in engagement of the frusto-conical surface 266 with the legs268 of the collet 244, which may eventually apply a mechanical force(e.g., a gripping or clamping force) to the catheter 108. The firstcoupler 204 (e.g., the collet 244) is preferably configured to ensurethat the gripping force on the catheter is greater than the intendedbreakaway force of the connector 200. As a result, when a traction forceis applied to the tube 102 and the catheter 108, the couplers 202 and204 separate before the catheter 108 dislodges from the first coupler.

Preferably, the legs 268 of the collet 244 are configured to engage andgrip the catheter 108 only after the seal 238 has been compressed. As aresult, axial catheter movement resulting from seal compression may beaccommodated before the collet immobilizes the catheter 108.

The catheter 108 may be configured such that it can be satisfactorilyimmobilized by the collet 244 without occlusion of the fluid passageway.For example, in one embodiment, the catheter could be made from anelastomeric material (pure or blended) such as a polymer, silicone, orthe like. Exemplary embodiments of the catheter 108 are described inmore detail below.

The tube 102, may, on the other hand, be constructed from conventionalmedical tubing such as polyurethane, silicone, or co-extrusions such assilicone/nylon or silicone/polyurethanie. Alternatively, the tube 102could be made from plasticized polyvinyl chloride (e.g., flexible PVC).In one embodiment, the tube 102 may have an inner diameter of about 0.07millimeters (mm) to about 0.08 mm (e.g., about 0.076 mm) and an outerdiameter of about 1.4 mm to about 1.5 mm (e.g., about 1.47 mm). Whileexemplary embodiments of the catheter and tube are so described herein,variations in material, construction, and size of the catheter 108 andtube 102 are certainly possible without departing from the scope of theinvention.

Once the housing 220 is completely threaded onto the attachment member218, the first coupler 204 is generally configured as shown in FIG. 4.The second coupler 202 may then be positioned proximate the firstcoupler 204 such that the bore 206 is generally aligned with theengagement portion 219. The engagement portion may then be slid into thebore 206 such that the roller 304 contacts the outer surface 222 of theengagement portion. This contact results in the roller assembly 301,e.g., the roller 304, being displaced outwardly (upwardly in FIG. 4)against the biasing force of the spring 306. The roller 304 may thenroll along the engagement surface 224 until it reaches the rampedsurface 228, at which point the roller may roll down the ramped surfaceand engage (contact) the grooved surface 226.

The biasing force of the spring 306 tends to keep the roller assembly301 engaged with the grooved surface 226 during operation. To preventbacklash in the connector 200, the second coupler 202 and the firstcoupler 204 may include corresponding abutting surfaces 282 and 284,respectively (see FIG. 4), that contact one another once the couplersare fully connected as shown in FIG. 3.

While not wishing to be bound to any particular embodiment, the rollerassembly may utilize an axle 302 having a diameter of about 0.050 inches(in) and the roller 304 (which may be made from acetal resin, PEEK,nylon, or the like) may have an outer diameter of about 0.09 in. In thisembodiment, the grooved surface 226 may be recessed about 0.021 in belowthe engagement surface 224, and the ramped Surface 228 may form an angleof about 50 degrees from the engagement surface.

As the second coupler 202 is attached to the first coupler 204, theneedle 208 associated with the second coupler may pierce the septum 230associated with the first coupler 204, thereby providing a fluid pathfrom the second tube 102 to the first tube (e.g., the catheter 108). Asa result, therapeutic agent contained in the infusion pump 106 (seeFIGS. 1A-1B) may be delivered to the body through the tube 102 andcatheter 108 in accordance with any desired infusion profile.

The retention device 300 is configured to release the first coupler 204from the second coupler 202 once a predetermined traction force (the“breakaway force”) is applied between the couplers, e.g., between thetube 102 and the catheter 108. In the illustrated embodiment, variousfeatures affect the breakaway force including, for example, the depth ofthe grooved surface 226, the angle of the ramped surface 228, thediameter of the roller 304, the friction of the roller about the axle302, and the spring force of the spring 306. While not wishing to bebound to any particular range of parameters, embodiments of the presentinvention may provide a connector 200 having a breakaway force of about1 pound force (lbf) to about 10 lbf and, preferably about 1 lbf to about5 lbf, and more preferably, about 1.5 lbf to about 3 lbf.

When the predetermined traction force is reached, the roller 304 maymove radially outward as it rolls from the grooved surface 226, alongthe ramped surface 228, to the engagement surface 224. The roller 304may continue to roll along the engagement surface 224 until the couplersseparate.

While described and illustrated herein utilizing the retention device300, other retention mechanisms are possible without departing from thescope of the invention. For example, FIGS. 8A and 8B illustrate analternate retention device 400. In this embodiment, the device includesa roller assembly having an axle 402 and a roller 404 rotatable aboutthe axle. The axle 402 may be formed as part of a spring clip, e.g.,C-shaped clip 406. The clip 406 may be configured to fit within acircumferential groove 408 formed in the body 410 of a second coupler.The roller 404 may be similarly contained within a slot 412 formed inthe body. The body 410, while only partially illustrated in FIGS. 8A and8B, is understood to be substantially similar to the body 205 of thecoupler 202 described above (e.g., it includes a bore 414 to receive theattachment member 218 substantially as described above). A sleeve 416similar to the sleeve 216 already described herein may also be included.

As with the retention device 300, the roller assembly, e.g., roller 404,may include a contact surface 418 formed by the outer surface of theroller. The contact surface 418 may form a secant through the bore 414of the tubular body 410 when the roller is in a first position as shownin FIG. 8B. When the attachment member is inserted into the bore 414,the roller 404 may move to a second position (see broken linerepresentation of axle 402) wherein the contact surface is locatedoutside of the bore. Movement of the roller 404 may be accommodated viadeflection of the clip 406 as may occur during insertion and removal ofthe first coupler 204 from the bore 414.

As with the device 300, the device 400 may engage the outer surface 222of the attachment member 218 (see FIG. 4) in rolling contact. Moreover,the roller 402 may be biased in a generally radial direction to maintainrolling contact with the attachment member 218 of the first couplerduring insertion/removal.

Connectors in accordance with embodiments of the present inventionprovide tubing/catheter couplers that breakaway or separate from oneanother when a predetermined traction force is applied to the couplersand/or to their associated tubes/catheters. Moreover, the retentiondevice that interconnects the two couplers may minimize frictionalengagement therebetween by providing rolling contact engagement. As aresult, the breakaway force required to separate the couplers issubstantially repeatable, avoiding the variability commonly associatedwith friction-based retention interfaces. Connectors in accordance withembodiments of the present invention further provide an upstream coupler(e.g., a coupler attached to an implanted catheter) that minimizesexposure to contamination even when the couplers of the connectorseparate. Accordingly, replacement or sterilization of the upstreamcatheter and/or coupler may be unnecessary in the event inadvertentseparation of the connector occurs.

Connectors in accordance with embodiments of the present inventionfurther provide a fluid flow path with minimal dead volume (the staticvolume that is filled before fluid is transferred through theconnector). Reduced dead volume is advantageous as it may decrease thevolume of wasted therapeutic agent. In the illustrated embodiment ofFIG. 3, the connector (e.g., the region 286 between the second tube 102and the needle 208, and the region 288 between the septum 230 and theseal 238) is designed to provide a low dead volume. For instance,connectors in accordance with embodiments of the present invention mayhave a dead volume of less than 20 microliters, and preferably less than10 microliters, e.g., nominally about 7 microliters.

Catheters

As described above, the first tube or catheter 108 may be implanted andused to deliver the therapeutic agent to the body. Accordingly, thecatheter 108 may be configured such that it can be satisfactorilyimmobilized by the collet 244 without occlusion of the fluid passageway.For example, as stated above, the catheter could be made from anelastomeric material (pure or blended) such as a polymer, silicone, orthe like.

While some exemplary catheters may be constructed as generally uniformtubes, catheters in accordance with other embodiments of the inventionmay be configured to include an elongate tubular core or core member 107(see, e.g., FIG. 7A) made from longitudinally flexible tubing that isresistant to compression and collapse, e.g., glass (e.g., silica orquartz) tubing, PEEK tubing, or stainless steel tubing. FIGS. 9A-9Billustrate an exemplary catheter having such a construction.

The core 107 may include a proximal end positioned at or near theproximal end 116 of the catheter 108, and a distal end positioned at ornear the distal end 110 of the catheter as shown in FIG. 9A. The core107 may also include a tubular body forming a lumen 117 spanning betweenthe proximal and distal ends of the core. In the illustrated embodiment,the tubular core 107 may have an inner (e.g., lumen 117) diameter ofabout 80 micrometers to about 120 micrometers (e.g., about 100micrometers) and an outer diameter of about 200 micrometers (e.g., about193 micrometers), yielding a radial or wall thickness of about 50micrometers or less. An exemplary core 107 may be a flexible syntheticfused silica capillary having an optional thin protective polymer (e.g.,polyimide) coating (forming an intermediate layer between the core andan outer covering or jacket 109) such as the TSP line of products soldby Polymicro Technologies, LLC, of Phoenix, Ariz., USA.

The flexible outer covering or jacket 109 may be formed over the tubularcore 107, e.g., it may surround the tubular core and be secured orotherwise fixed relative to the core's outer surface. While the flexibleouter covering or jacket is described in the illustrated embodiments asan elastomeric jacket 109, this construction is not limiting as otherouter covering embodiments are certainly possible without departing fromthe scope of the invention.

In one embodiment, the jacket 109 may have an outer diameter that isabout 3 or more times larger, and preferably about 4 or more timeslarger (e.g., about 4 to about 6 times larger), than the outer diameterof the tubular core 107. For example, the outer diameter of the jacket109 may be about 0.8 mm to about 1.2 mm (e.g., about 1 mm).

The jacket 109 may be formed of an elastomeric material having a radialcompliance that is greater than a radial compliance of the tubular core107. In one embodiment, the elastomeric jacket 109 is made from amaterial selected from the group consisting of polyurethane andsilicone. As a result of using a relatively compliant material, theflexible outer covering or jacket may permit high mechanicalclamping/indentation forces to be applied to the catheter 108 (e.g., bythe connector 200 or, as described below, by the anchor 1200) toimmobilize it, while the more radially rigid tubular core 107 preventscatheter occlusion under such high forces. While not limited to anyparticular hardness, the jacket 109 may, in one embodiment, have ahardness of about 50 to about 60 Shore D, e.g., about 55 Shore D (at thecompletion of manufacture).

As illustrated in FIG. 9A, the tubular core 107 may, in someembodiments, protrude longitudinally beyond the jacket or covering 109at one or both ends of the catheter (e.g., beyond a distal end 119 ofthe jacket as shown) by a distance 124 of, e.g., about 10 mm or more.Stated alternatively, the jacket 109 may terminate a distance of about10 mm short of the distal end of the core 107.

FIG. 9B illustrates a section view of the catheter 108 taken along line9B-9B of FIG. 9A. As illustrated in this view, the catheter mayoptionally include one or more locator markings. For instance, a markerband, e.g., a fluoroscopic or radiopaque marker band 131, may be locatedat or near the distal end 119 of the outer covering (e.g., jacket 109).The band 131 may include platinum, iridium, or a similar material thatmay permit detection of the band with fluoroscopic or x-ray imaging.Such a configuration may be beneficial, for example, during implantationof the catheter into the body.

The catheter 108 may further optionally include other locator markings,e.g., longitudinal markings 132 (only two shown on catheter 108 in FIG.9A). The longitudinal markings 132 may be evenly spaced and include somecolorant (e.g., titanium dioxide) to permit visual indication ofcatheter implant depth. The markings 132 may also be used to determineproper placement of the proximal end 116 of the catheter within theconnector 200.

FIGS. 10A-10E illustrate a catheter, e.g., a catheter 508, in accordancewith an alternative embodiment of the invention. The catheter 508 may besimilar in some respects, and be used in place of, the catheter 108.

Like the catheter 108, the catheter 508 may include a radially rigid yetlongitudinally flexible tubular core or core member 507 (of a firstmaterial, e.g., PEEK tubing) having a distal end and a proximal end. Aflexible outer covering or jacket 509 may surround the core (see, e.g.,FIGS. 10A and 10D). However, instead of a single tubular core memberextending along the catheter, the catheter 508 may incorporate aseparate tubular tip or tip member 510, e.g., a composite tip membermade of a second material different than a material of the core member507. The tip member 510, like the core 507, may also have proximal anddistal ends as shown in FIG. 10A.

The tip 510 may be configured as a relatively rigid (both radially andlongitudinally) member. For instance, in one embodiment, the tip 510 maybe formed from fused silica glass tubing. In another embodiment, the tip510 may be made from steel, e.g., type 304 stainless steel hypodermictubing. The proximal end of the tip 510 may be positioned to abut thedistal end of the core 507 (e.g., be positioned in abutting contact atlocation 511 as illustrated in FIGS. 10A and 10B) such that a generallycontinuous lumen extends or is established from the proximal end of thecore 507 to the distal end of the tip 510. While described herein asabutting one another, in practice the two members 507 and 510 may have asmall gap therebetween, e.g., the adjacent ends of the tip and core maybe positioned to be near, rather than abut, one another. Nonetheless,the jacket 509 may effectively seal the interface and provide agenerally continuous lumen as described.

While not wishing to be bound to any particular construction, thematerials and geometry of the tip 510 and core 507 may be selected toproduce a bending stiffness ratio (ratio of the bending stiffness of thetip to bending stiffness of the core) of about 24:1.

The jacket 509 may surround or encase longitudinal sections or portionsof both the tip 510 and the core 507 as further described below. As withthe catheter 108, the distal end of the tip 510 may protrude a presetdistance beyond a distal end of the jacket as shown in FIG. 10A. The tip510 may also extend into the jacket 509 a distance that is sufficient toensure retention of the tip. For example, in one embodiment, thecatheter length (including the protruding length 124 of the tip 510) isabout 400 mm (about 16 inches), while the tip extends into the jacket adistance 134 of about 20 mm, (about 0.8 inches).

FIG. 10C illustrates a cross section of the catheter 508 taken alongline 10C-10C of FIG. 10A, while FIG. 10D illustrates a section view ofthe distal end of the jacket 509. These views clearly illustrate themarker band 131 (as described above) formed, at least in one embodiment,as a ring located around the tip 510 and surrounded by the jacket 509.In one embodiment, the marker band may extend a short distance 136,e.g., about 1 mm, from the end of the jacket. As with the catheter 108,the catheter 508, e.g., jacket 509, may also include the longitudinallength markings 132 (only two shown in FIG. 10E). The markings 132 andband 131 may be visible from any radial position, e.g., they may extend360 degrees around the catheter.

In still yet other embodiments, strengthening members, e.g., braidedmembers helically-wound about a longitudinal length or portion of thecatheter, and/or straight longitudinal members, may be provided. Forexample, strengthening members may be sandwiched between the core andthe flexible outer covering or jacket (e.g., such that they aresurrounded by the jacket), or alternatively embedded within the jacket.Exemplary strengthening members may include polyester (e.g.,polyethylene terephthalate (PET)), synthetic polymers such as Kevlarbrand fiber (sold by E.I. du Pont de Nemours of Wilmington, Del., USA),and liquid crystal polymers. In other embodiments, steel may be used toform the strengthening members. Such strengthening members may beincorporated into any of the catheter embodiments (e.g., 108, 508, and608, the latter of which is described below) described herein.

An exemplary catheter 608 incorporating such strengthening members isshown in FIGS. 11A-11E. The catheter 608 may be similar in most respectsto the catheter 508. For instance, it may include a core or core member607 (e.g., PEEK core) and a flexible outer covering or jacket (e.g.,polyurethane jacket) 609 optionally having locator markings such asmarker band 131 and longitudinal markings (not shown) as alreadydescribed herein. As a result, a section taken through line 11D-11D (seeFIG. 11D) is similar in most respects to the corresponding section takenthrough line 10C-10C of FIG. 10A (see, e.g., FIG. 10C).

A tip 610 substantially similar to the tip 510 already described abovemay also be included. The jacket 609 may encase at least sections ofboth the core 607 and the tip 610 as further described below. Onceagain, as shown in FIG. 11B, the tip 610 may abut the core 607 at alocation 611 (e.g., offset a distance 634 from the distal end of thejacket) such that a continuous lumen is formed through the catheter. Thetip 610 may further extend from the distal end of the jacket by adistance 124 as already discussed above.

Unlike the catheter 508, however, the catheter 608 may further includeone or more strengthening members 605 extending along at least a portionof a length of the catheter. In the illustrated embodiment, thestrengthening members 605 may form a tubular braid located coaxiallyabout portions of one or both of the core 607 and the tip 610 (note: themembers 605 are shown diagrammatically in the figures). Stated anotherway, the individual members 605 may include a plurality of first braidedmembers 605 a helically wound about a longitudinal portion of thecatheter 608 (e.g., about at least portions of the core and/or the tip510) in a first or clockwise direction, and a plurality of secondbraided members 605 b helically wound about the longitudinal portion ina second, opposite or counterclockwise direction (as shown in FIG. 11C)such that individual members interweave with one another. Otherembodiments may include, alternatively or in addition, one or morelongitudinal strengthening members 606 extending along portions of oneor both of the core and the tip as also shown in FIG. 11C.

In one embodiment, the strengthening members 605 (e.g., the members 605a and 605 b) include sixteen separate, 0.05 mm (0.002 inch) diameter PETfibers that are partially embedded within the jacket 609 as shown inFIGS. 11C and 11E, the latter of which is a section view taken alongline 11E-11E of FIG. 11B. These strengthening members 605 may extendalong at least a portion of the catheter 608. For example, in theembodiment illustrated in FIG. 11A, the members 605 may terminate adistance 138 short of the distal end of the jacket 609. Thestrengthening members 605 may also extend towards the proximal end ofthe catheter at least beyond the location 611 (e.g., so that theysurround the distal end of the core 607 and the proximal end of the tip610 as shown) to increase strain relief to the catheter in the vicinityof the location 611. In the illustrated embodiment, the strengtheningmembers 605 may extend to the proximal end of the catheter 608.

While not wishing to be bound to any particular embodiment, theexemplary catheter 608 may again be about 400 mm (16 inches) long(including the protruding tip 610). The distance 138 (the terminationoffset of the strengthening members 605 from the distal end of thejacket 609) may be about 10 mm (0.4 inches), while the distance 634 atwhich the core member 607 abuts the tip member, may be about 20 mm (0.8inches). The preset distance 124 may again be about 10 mm (0.4 inches),which may thus be equal to about ⅓ of the total length of the tip member610. The small diameter, protruding distal tip of the core may assistin, for example, penetrating tissue during implantation.

The catheter embodiments illustrated in FIGS. 10A-10E and 11A-11E mayprovide a catheter having: a distal end section 140 defined by theprotruding (e.g., stainless steel or glass) tip member 610; a proximalend section 142 defined by the portion of the catheter incorporating thecore member 607; and a medial section 144 between the distal andproximal end sections (see, e.g., FIG. 11A). The jacket 609 may extendalong and surround both the medial section 144 and the proximal section142. The distal end section 140 may thus have a longitudinal portionwith a uniform outer diameter less than an outer diameter of one or boththe proximal end section 142 and the medial section 144. As a result ofthe different material of the core 607 and tip 610, the distal endsection 140 may also have a bending stiffness that is greater than abending stiffness of the proximal end section 142.

The outer covering or jacket 109 may be applied to the respectivetubular core 107 in any known fashion (the following description mayalso apply to the jackets 509 and 609 and their respective cores 507 and607). For example, it may be applied over the core 107 through asecondary extrusion process. Alternatively, the outer covering or jacket109 may form a tube which slides over the tubular core 107 withclearance. In the case of the latter, two or more abutting tubingsegments may be employed to produce the jacket 109. These multiplesegments may also be beneficial in providing the proper spacing for thelongitudinal markings 132. A shrink-wrap tube may then be placed overthe assembled tubes and the entire assembly heated. Any optionalstrengthening members (e.g., woven fibers 605) may also be placed overthe tubular core 107 or the outer covering 109 before the heat shrinktube is applied. Subsequent heating of the assembly may cause the outercovering 109 to melt and the shrink-wrap tube to constrict. Thus, theshrink-wrap tube may force the melted outer covering (and optionalstrengthening members) inwardly towards the tubular core 107 and bond tothe same. The shrink-wrap tube may then be removed to produce thecatheter 108.

Anchors

Embodiments of the instant invention may also be directed to anchordevices and assemblies and to corresponding systems and methods forsecuring a therapy delivery device relative to a surface, e.g., asurface of a body. For example, exemplary anchor assemblies and devicesdescribed herein may be configured to secure a therapy delivery device(such as a stimulation lead or infusion catheter 108) that is partiallyimplanted through a skin-covered body portal. Moreover, these anchorassemblies may be manipulated from a location outside of the skin (e.g.,outside of the patient's body) to release the therapy delivery device,e.g., at therapy completion. Once released, the device may be withdrawnfrom the body, e.g., by application of an external force or otheraction. As a result, the therapy delivery device may be removed from thepatient without a separate surgical procedure.

While the term “skin” is used herein to identify an exemplary coveringof the body portal, this term is not to be read in a limiting sense.That is, embodiments of the present invention are equally applicable toportals covered by most any material, including grafts, medicaldressings, and other synthetic and biologic coverings, as well as touncovered portals.

In the described embodiments, an anchor portion of the anchor assembly1201 is configured as the burr hole anchor 1200 (see FIG. 1A). Theanchor may be part of the system 100 for infusing a therapeutic agentinto the patient's brain via the brain catheter 108 passing through theburr hole 112 formed in the skull. The anchor 1200, which may besubdermally located, may be used to secure the catheter relative to theburr hole. The anchor assembly 1201 may include the anchor 1200 as wellas the lock member 1208 to release the catheter 108 from the anchor,e.g., at therapy completion.

While described herein in the context of burr hole anchors andcorresponding infusion systems, anchor assemblies and systems inaccordance with embodiments of the present invention may find use inmost any medical (or non-medical) application that involves accessthrough a portal formed in a surface.

FIGS. 1A and 1B illustrate the exemplary implantable medical system,e.g., brain infusion catheter system 100. Once again, the exemplaryinfusion system 100 may include the first medical tube, e.g., the braincatheter 108, partially implanted within the body 101. The secondmedical tube 102 may also be provided having its distal end 104 coupledto an external reservoir (e.g., infusion pump 106) containing a volumeof the therapeutic agent. In the illustrated example, the brain catheter108 has an indwelling portion, e.g., the distal end 110, implantedthrough a body portal (e.g., burr hole 112) and located at apredetermined location within the brain 114 of the patient. An externalportion (e.g., the proximal end 116) of the brain catheter 108 may beroutable through skin covering the skull 113 (see FIG. 12) and extendoutside the body 161 where it connects to the corresponding proximal end118 of the tube 102, e.g., via the connector 200.

The breakaway connector 200, as described above, may include the firstcoupler or connector portion 204 coupled to the brain catheter 108 andthe second coupler or connector portion 202 coupled to the tube 102 asshown in FIG. 1B. Once again, the first coupler 204 may be operable toseparate from the second coupler 202 when a traction force appliedbetween the tube 102 and the brain catheter 108 reaches a predeterminedthreshold value. That is, the connector 120 may be configured toseparate once a predetermined traction force is applied across theconnector, e.g., between the two tubes 102 and 108 joined by theconnector. The connector 200 may utilize either frictional ornon-frictional (e.g., magnetic) interfaces to achieve the breakawayfunction. As discussed above, the breakaway function may be beneficialto reduce inadvertent catheter dislodgement as the result of snagging ofthe tube 102 or other system 100 components on surrounding objects.

As already described herein, the connector 200 may be supported, e.g.,pivotally supported, by the optional headgear apparatus 120 (see FIGS.1A and 2B) formed from a series of adjustable, fabric (e.g., nylonwebbing) or elastic bands. The headgear apparatus 120 may hold theconnector, e.g., via a connection with the first coupler 204, during theimplantation. While illustrated as supported by the headgear apparatus120 in FIG. 1A, the connector 200 could alternatively be generallyunsupported, e.g., supported only by the free proximal ends 116 and 118of the catheter 108 and tube 102, respectively, without departing fromthe scope of the invention. The exemplary breakaway connector 200 isdescribed elsewhere herein and in related U.S. patent application Ser.No. 11/589,694, filed on Oct. 30, 2006). While the exemplary connector200 is described herein, other embodiments that utilize connectorconfigurations providing an alternate breakaway configuration arecertainly possible. For example, connectors using a snap-fit lock (e.g.,similar to that disclosed by Lickliter in U.S. Pat. No. 6,902,207) orthose incorporating a magnetic lock (e.g., similar to that disclosed byCator in U.S. Pat. No. 3,181,895) could be used.

The system 100 illustrated in FIGS. 1A and 1B may further include aportal anchor device, e.g., the burr hole anchor 1200. The anchor 1200may attach to the body, e.g., to the skull 113, in or near the burr hole112. The anchor 1200 may be used to selectively immobilize the catheter108 relative to the burr hole 112. In the illustrated embodiment, all,or substantially all, of the anchor 1200 is positioned subdermally(e.g., below the skin). The anchor 1200 forms part of the anchorassembly 1201 that further includes the lock member 1208 capable ofselectively releasing the brain catheter 108 from the anchor. The lockmember (further described below) may be releasable, or otherwiseactuatable, from a location outside of the skin.

While the embodiments described and illustrated herein are directed tocatheter implantation and anchoring, this is not limiting as most anyother therapy delivery device (e.g., stimulation lead) may be used withthe anchor embodiments described herein without departing from the scopeof the invention.

FIG. 12 is a perspective view of the portal, e.g., burr hole, site andillustrates an anchor system in accordance with one embodiment of theinvention. The burr hole 112 may be formed through the skull 113 in aknown manner prior to catheter 108 implantation. In the illustrativeembodiment, the anchor 1200 includes a base 1202 that at least partiallysurrounds the portal (burr hole 112) and is attachable to tissuesurrounding the portal, e.g., to the skull 113, with fasteners, e.g.,bone screws 1204, or the like. The anchor 1200 may further include aretainer 1206 (shown exploded from the base in FIG. 12) that isattachable or otherwise securable to the base 1202 and is capable ofselectively gripping or otherwise immobilizing the catheter 108. In someembodiments, the base 1202 may be optional. That is, the retainer 1206could be positionable in or near the burr hole portal beneath the skin,where it may be secured to the skull in another manner, e.g., friction.The retainer 1206 may include a movable arm 1210 and a latch or latchingdevice 1212, each of which is described in more detail below. Thecomponents of the retainer 1206 (e.g., body portion 1230 and arm 1210)may be constructed of most any biocompatible material, but are, in oneembodiment, made from titanium.

FIG. 13 illustrates a cross sectional view of the anchor assembly 1201and catheter 108 after implantation. As evident in this view, the anchor1200, e.g., the base 1202 and retainer 1206, are operable to besubdermally located (i.e., beneath the skin 111). As FIG. 13 furtherillustrates, the arm 1210 may move from a first or unlocked positionshown in FIG. 12 (corresponding to the retainer being in a first orunlocked configuration), to a second or locked position shown in FIG. 13(corresponding to the retainer being in a second or lockedconfiguration). In the second position, opposing retaining surfaces 1234and 1242 (see FIG. 14) may mechanically engage the catheter 108 and holdit in place relative to the burr hole 1112. The lock member 1208 may beconfigured to hold or secure the arm 1210 in the second position. Thecatheter 108 and the lock member 1208 may, at the completion ofimplantation surgery, extend outwardly through the skin 111 covering theskull 113 and the now-implanted anchor 1200.

FIG. 14 is a perspective view of the base 1202 with the retainer 1206exploded to illustrate an exemplary construction. In this embodiment,the retainer 1206 includes the planar, disk-shaped body or body portion1230 that defines a mounting plane. The base 1202 may form a peripheralportion of the anchor 1200 that defines a central opening 1214. An innersurface of this peripheral portion may form a ledge 1216 to receive andsupport a peripheral edge 1232 of the body portion 1230 when theretainer is attached to the base in or near the central opening.

The ledge 1216 may, in one embodiment, be formed by a plurality of teeth1218 protruding from the inner surface of the peripheral portion intothe central opening 1214. A recess 1220 may be defined between adjacentpairs of the plurality of teeth 1218.

The body portion 1230 may further include a first retaining surface 1234defined by an edge of a cutout or pie-shaped opening 1236 extendingthrough the peripheral edge 1232. The first retaining surface 1234 mayspan from an interior of the body portion 1230 to a location at or nearthe peripheral edge 1232. As further explained below, the firstretaining surface 1234 may be configured to mechanically engage thecatheter 108 (not shown in FIG. 14) during use.

The arm 1210 may be movably, e.g., pivotally, attached to the bodyportion 1230. For example, the arm 1210 may include a second retainingsurface 1242 that joins first and second plate members 1238, 1240. Theplate members 1238, 1240 may form a clevis extending over both sides ofthe body portion 1230 when the arm 1210 is assembled with the bodyportion.

The two plate members 1238, 1240 may include openings 1244 that alignwith an opening 1246 in the body portion 1230 such that a pin 1248 maybe inserted through the openings (the pin 1248 may engage either the arm1210 or the body portion 1230 with interference) as shown in FIG. 15.The arm 1210 may thus pivot about an axis of the pin 1248. The secondretaining surface 1242, e.g., the arm 1210, is therefore movable,relative to the first retaining surface, between the first positionconfigured to receive the catheter 108 (see, e.g., FIG. 15), and thesecond position configured to mechanically engage the catheter (e.g.,via friction or via a biting or clamping action) against the firstretaining surface 1234 (see, e.g., FIG. 16). Thus, the catheter 108 maybe immobilized or otherwise locked relative to the anchor 1200 via apivoting motion applied to the arm 1210.

In embodiments wherein the catheter 108 is engaged via a biting actionor a high frictional force, the catheter may be constructed of acompliant material that can withstand the contact forces of the firstand second retaining surfaces as already described herein (seedescription of catheters 108, 508, and 608).

When the arm 1210 is in the first position, the second retaining surface1242 may be oblique to the first retaining surface 1234, e.g., a linecontained within the second retaining surface may intersect a linecontained within the first retaining surface at an acute angle. Thisconfiguration provides for a larger opening in which to initially insertand position the catheter as shown in FIG. 15. However, when the arm isin the second locked position (see, e.g., FIG. 16), the first and secondretaining surfaces are generally parallel to one another to permitgenerally equivalent contact force on the catheter regardless of thecatheter's position along the retaining surfaces.

In addition to the anchor 1200, the anchor assembly 1201 may furtherinclude the lock member 1208. The lock member 1208 may be formed by anelongate member or cord 1250 that is removably coupled to the anchor,e.g., to the body portion 1230 of the retainer 1206. In one embodiment,the lock member 1208, e.g., the cord 1250, protrudes away from the bodyportion 1230 generally orthogonally from the mounting plane defined bythe body portion. The cord 1250, in the illustrated embodiment, isconfigured to protrude through an opening or incision in the skin 111 asshown in FIG. 13. In one embodiment, the elongate cord 1250 is made fromstainless steel stranded cable, e.g., 1×7, 1/64 inch diameter.

The exemplary lock member 1208 may also include a first end 1252 and asecond end 1256. The first end 1252 may be attachable to the bodyportion 1230, e.g., detachably inserted into or otherwise receivedwithin an opening 1254 formed in the body portion (see, e.g., FIG. 14).The opening 1254 may position the lock member 1208, e.g., the first end1252, such that it may interact with the arm 1210 as further describedbelow. In the illustrated embodiment, the lock member 1208 is securelyretained in the body portion 1230 during the implantation period and upuntil the lock member 1208 is intentionally removed. Such secureretention may be achieved in any number or ways, some of which aredescribed in more detail below.

The first and second ends 1252 and 1256 of the lock member 1208 may beformed by sleeves 1252 a and 1256 a, respectively, which are attached,e.g., crimped or adhered, to the cord 1250. By utilizing the sleeve 1252a at the first end 1252, the tolerance of the first end 1252 relative tothe opening 1254 may be closely controlled without concern for the size,material, or structure of the cord 1250. In one embodiment, the sleeves1252 a and 1256 a are made of stainless steel.

The second end 1256, e.g., the sleeve 1256 a, of the lock member 1208may be used to provide a gripping surface to assist in lock memberremoval. In one embodiment, the sleeve 1256 a may be used to secure anoptional grasping loop 1258 as shown in FIGS. 12 and 14. The loop 1258may be sized to permit insertion of a finger to assist the clinicianwith lock member removal.

The lock member 1208 is movable from an engaged state in which the lockmember is coupled to the retainer 1206 to hold the arm 1210 in thesecond position (see, e.g., FIGS. 13 and 16), to a disengaged state inwhich the lock member releases the arm from the second position. Thelock member 1208 is preferably movable from the engaged state to thedisengaged state via manipulation of the lock member from outside theskin, e.g., via application of a traction force to the second end 1256of the lock member to remove the latter from the retainer 1206.

The lock member 1208 is configured to secure or lock the arm 1210, e.g.,the second retaining surface 1242, in the second or locked position, asshown in FIG. 16, by engaging a locking portion 1260 of the arm asfurther described below. While not visible in FIG. 16, the arm mayinclude a locking portion 1260 on both the first plate member 1238 andthe second plate member 1240 (see FIG. 20).

The lock member 1208 may be retained within the body portion 1230 via avariety of methods. For example, in one embodiment, the first end 1252may be sized such that it is received into the opening with aninterference or press fit, wherein the interference provides a suitableretention force. In another embodiment, the opening 1254 may form a slotthat receives the first end 1252. Such a slot may provide advantagesincluding added flexibility of the body portion 1230 duringinsertion/removal of the lock member 1208. As a result, tolerancecontrol between the first end 1252 and the body portion 1230 couldpotentially be relaxed.

In yet another embodiment, a cantilever spring may be provided that isintegral or otherwise associated with the opening 1254. The spring andopening may both provide a suitable retention force between the lockmember 1208 and the body portion 1230 without necessitating the elevatedtolerance accuracy typically associated for press fits. In still yetanother embodiment, the first end 1252 of the locking member 1208 may besized to freely slip into the opening 1254. The locking portion 1260 ofeach arm 1210 could then mechanically interfere with the first end 1252to provide a frictional retention force. In one embodiment, thisretention force may be about 0.1 pounds force (lbf) to about 1.1 (lbf).However, this range is exemplary only and embodiments that release uponthe application of most any force are certainly possible withoutdeparting from the scope of the invention. In this embodiment, eachlocking portion 1260 may basically form a cantilevered spring thatallows insertion, despite the mechanical interference, of the first end1252 of the lock member 1208 into the body portion 1230. In still otherembodiments, a detent bump 1261 (see FIG. 16) may be provided thatcreates a detent action to releasably hold the arm 1210 in the unlockedposition. Due to the spring-like action of each locking portion 1260, asuitable detent holding force may be created.

The retainer 1206 may further include the latch 1212 as shown in FIG. 14(also shown in section in FIGS. 19A and 19B). The latch 1212 may be usedto secure the retainer 1206 relative to the base 1202. While shown inFIG. 14 as a separate component attached to the body portion 1230, thelatch 1212 could, in other embodiments, be formed as an integral part ofthe retainer, e.g., deflectable snap fit tabs as further describedbelow.

The latch 1212 may include a latch plunger 1262 that is biased outwardlyby a biasing member, e.g., spring 1264. The latch plunger 1262 may beformed by first and second plate members 1266 and 1268 that are joinedat a nose 1270. A pin, e.g., retaining pin 1271 may also extend betweenthe plate members 1266 and 1268. The latch plunger 1262 may thus form aclevis that extends over both sides of the body portion 1230 whenassembled.

The latch 1212, e.g., latch plunger 1262, is preferably movable from afirst or unlatched position that is at or within the peripheral edge1232 of the body portion 1230 (see, e.g., FIG. 15), to a second orlatched position extending beyond the peripheral edge of the bodyportion (see, e.g., FIG. 16). The latch plunger 1262 is preferablybiased towards the latched position by the biasing member (e.g., by thespring 1264).

A stop, such as tab 1272, may be provided on one of the plate members,e.g., the lower plate member 1268. The tab 1272 may be used to hold thelatch plunger 1262 in the unlatched position. For example, the tab 1272may include an opening 1274 that aligns with an opening 1276 in the bodyportion 1230 when the latch 1212 (e.g., the latch plunger 1262) is inthe first unlatched position. A pin 1278, which may be fixed (e.g., viainterference or adhesive) within the opening 1276, may then engage theopening 1274 (preferably with clearance) to hold the latch plunger 1262in place.

The body portion 1230 may further include an opening, e.g., slot 1280,that receives and retains the spring 1264. A finger 1282 may extend intothe slot 1280 to assist with spring retention. The retaining pin 1271,which may be installed when the latch plunger 1262 is in the first orunlatched position, may also extend through the slot 1280. As a result,the pin 1271 may limit the outward movement of the biased latch plunger1262 and prevent component separation.

The body portion 1230 may define other features, e.g., slots 1284 and1285, that assist in assembly and/or manipulation of the retainer asfurther described below. The arm 1210 may also include a slot 1286 that,in conjunction with the slots 1284 and 1285, assists in movement of thearm.

FIG. 15 illustrates a perspective view of the anchor 1200 with a portionof the base 1202 cut-away to show the ledge 1216 in more detail. In thisview, the arm 1210 is shown in the first or unlocked position and thelatch 1212 is shown in the first or unlatched position. As illustratedin this view, the base 1202 may be of two-part construction. A first orinner portion 1222 may form the ledge 1216 and its associated structure(e.g., the teeth 1218) to support the retainer 1206. A second or outerportion 1224 may include features (e.g., fastener attachment points)that assist in attaching the base 1202 to tissue (bone surface)surrounding the burr hole 112. The first portion 1222 may be relativelyrigid (as compared to the second portion 1224) to ensure that thecatheter 108 is adequately immobilized. The second portion 1224 ispreferably more compliant than the first portion 1222. The compliance ofthe second portion 1224 allows the anchor 1202 to generally conform tothe local shape of the skull 113 (see FIG. 12). In one embodiment, thefirst or inner portion 1222 of the base 1202 is made from titanium,while the second or outer portion 1224 is made from an implantablethermoplastic such as amorphous polyamide.

The second portion 1224 may be pivotally coupled to the first portion1222 of the base 1202 via a ball and socket arrangement as shown in thecut-away portion of FIG. 15. For example, the inner surface of thesecond portion 1224 may include an inner circumferential lip 1225 thatis convex in cross section as shown in FIG. 15. This lip 1225 may fitwithin an outer circumferential recess of the first portion 1222 that isconcave in cross section as shown in FIG. 15. While the base 1202 isillustrated as having a two part construction, such a configuration isnot limiting. For example, other embodiments of the base 1202 mayutilize a single piece construction without departing from the scope ofthe invention. Such a single piece construction could include integralflexing elements, or flexures, to create a rigid portion and aconforming portion of the base 1202.

Other variations of the base 1202 are also possible. For example, whilenot illustrated herein, the base 1202 could be formed with a radial slotextending entirely through the ring that forms the base (e.g., yieldinga C-shaped base). Such a construction may allow side loading of the base1202 over the catheter 108 after the catheter is positioned but beforethe stereotactic positioning apparatus is removed.

FIG. 16 illustrates the anchor 1200 of the anchor assembly 1201 with thelatch 1212 in the latched position and with the arm 1210 in the lockedposition. In the locked position, the arm 1210, e.g., the secondretaining surface 1242, mechanically engages the catheter 108 byclamping or pinching the catheter against the first retaining surface1234. To reduce stress on the catheter 108, curved transition surfaces1226 associated with either or both the first and second retainingsurfaces 1234 and 1242 may be provided. As further shown in this view,the locking portion(s) 1260 of the arm 1210 may be configured to contactthe lock member 1208 (when the arm is in the locked position) such thatthe arm is immobilized relative to the body portion 1230 of the anchor1200.

To further illustrate the movement of the arm 1210, FIGS. 17 and 18provide top views of the anchor assembly 1201. FIG. 17 illustrates theanchor assembly with the arm in the unlocked position and the latch inthe latched position, while FIG. 18 illustrated the anchor with the armin the locked position and the latch in the latched position (thecatheter 108 is removed from these views for clarity). As illustrated inFIG. 17, the locking portion 1260 may form a resilient finger that maydeflect to rest against the lock member 1208, e.g., against the firstend 1252, when the arm is in the first or unlocked position. During theimplantation procedure, the arm may be moved (e.g., pivoted about thepin 1248) to the locked position of FIG. 18 once the catheter 108 islocated at the desired position within the central opening 1214. The arm1210 may be moved to the locked position by, for example, inserting aninstrument such as forceps into the slots 1284, 1285, and 1286 anddrawing the second retaining surface 1242 of the arm towards the firstretaining surface 1234. A stop member, e.g., a protrusion 1289 formed onthe body portion 1230, may be provided to limit the movement of the arm1210 towards the first retaining surface, thus providing protectionagainst catheter over-compression.

When the arm reaches the locked position shown in FIG. 18, the lockingportion(s) 1260 of the arm 1210 may slide past the first end 1252 of thelock member 1208. When the locking portion 1260 clears the first end1252, it may return to an undeflected state. In this undeflected state,each locking portion 1260 of the arm 1210 is aligned with the first end1252 of the lock member 1208 such that a lock surface 1290 (see FIG. 17)abuts the first end of the lock member as shown in FIG. 18. In theillustrated embodiment, the lock surface 1290 could be concave in shapeto seat against the cylindrical shape of the first end 1252 of the lockmember 1208 when the arm is in the second position. Alternatively, thelock surface 1290 may be formed by one or more linear surfaces tangentto the first end 1252 as best illustrated in FIGS. 17 and 20. When thelock surface 1290 is engaged with the lock member 1208, the arm 1210,e.g., the second retaining surface 1242, may be held in the lockedposition shown in FIG. 18.

As mentioned above, the lock member 1208 may be retained in the bodyportion 1230 with an interference fit. However, in some instances, e.g.,when the arm 1210 is in the locked position as it is during infusion, itmay be beneficial to increase the lock member retention force.Accordingly, some embodiments of the catheter 108, as already describedherein, may be constructed with a lumen that is relatively rigid in(e.g., resistant to) radial compression. Such a catheter constructionmay increase the force applied to the first end 1252 of the lock member1208 by the locking portion 1260, and thus increase frictional retentionof the first end within the opening 1254 of the body portion 1230. Inone embodiment, the retention force, e.g., the force required to removethe first end 1252 from the body portion 1230, may be about 0.1 lbf toabout 3 lbf, e.g., about 0.5 lbf to about 2 lbf.

Prior to moving the arm 1210 to the locked position as described above,the retainer 1206 may first be latched or secured to the base 1202 usingthe latch 1212. Preferably, the retainer 1206 is secured to the basewith the latch 1212 before locking of the arm 1210 to preventundesirable transverse catheter movement during retainer latching.

FIG. 19A is a section view of the anchor 1200 taken along line 19A-19Aof FIG. 17 illustrating the latch 1212 in accordance with one embodimentof the invention. However, unlike FIG. 17, FIG. 19A shows the latch inthe first or unlatched position, while FIG. 19B shows generally the sameview as FIG. 19A, but with the latch in the second or latched position(e.g., a true section view of FIG. 17).

As illustrated in FIG. 19A and described above, the retainer 1206 may belocated within the central opening 1214 of the base 1202 where it may bepositioned to rest upon the ledge 1216. Once the retainer 1206 isrotationally positioned, relative to the base 1202, to the desiredorientation, the latch 1212 may be released to secure the retainer inplace. In the illustrated embodiment, the latch 1212 may be released byreleasing the tab 1272 from the pin 1278. Release of the tab 1272 may beaccomplished by inserting a surgical instrument, e.g., forceps, throughthe slot 1284 and applying a slight downward force to the tab asrepresented by arrow 1287 in FIG. 19A. Alternatively, a specialized tool(not shown) may be used. This tool may provide a properly-sized actuatorpoint, as well as an inherent limit stop, both of which may assist inthe release of the tab 1272. The force may deflect the tab 1272, asillustrated by the broken line representation in FIG. 19A, sufficientlyfor the tab to release from the pin 1278. Once the tab 1272 is released,the spring 1264 forces the latch plunger 1262 away from the body 1206 ofthe retainer 1206. That is, the spring pushes the plate members 1266,1268 and the nose 1270 outwardly towards the base 1202.

As the latch plunger 1262, e.g., the nose 1270, extends towards theinner portion 1222 of the base 1202, the spring 1264 also forces thebody portion 1230 against the opposite side of the base as shown in FIG.19B. When the latch 1212 is fully released or engaged (as shown in FIG.19B), the nose 1270 and the body portion 1230 are pressed againstopposing inner surfaces of the base 1202.

As illustrated in FIGS. 19A and 19B, the base 1202 may define a groove1291 bounded by the ledge 1216 and by an upper surface 1292. The ledgeand the upper surface substantially restrain the retainer 1206 againstmovement normal to the mounting plane of the body (i.e., along an axisof the central opening). Similarly, the biasing force of the spring 1264may substantially restrain the retainer 1206 against radial movementrelative to the base 1202. Alternatively (or in addition), a portion ofthe retainer (e.g., the pin 1278) may form a stop that limits movementof the latch plunger 1262 away from the latched position. This isaccomplished, in one embodiment, by an end 1273 of the tab 1272. The end1273 may abut the pin 1278 when movement of the latch plunger 1262 awayfrom the latched position occurs, thus assisting with maintaining thelatch in the latched position. As a result, the retainer 1206 may besecured within the central opening of the base 1202 via the latch 1212.

FIG. 20 illustrates a bottom plan view of the anchor after the latch1212 is moved to the second or latched position of FIG. 19B and beforethe arm is moved to the locked position. As illustrated in this view,the latch plunger 1262 of the latch 1212 may force the retainer 1206 toa location slightly off-center from the base 1202 such that the retainerand base are no longer concentric. As the retainer 1206 is shiftedtransversely to the base, lock members, e.g., tabs 1294 and 1296,attached to the body portion 1230 may each engage one of the recesses1220 of the base as shown. Engagement of the tabs 1294, 1296 with therecesses may reduce or eliminate excessive rotation of the retainer 1206relative to the base.

Embodiments of the present invention may further include methods fordelivering therapy via a partially implanted device extending through acovered portal such as the skin-covered burr hole 112. For example, anexemplary method may include securing the device (e.g., catheter 108)relative to the burr hole 112 with the subdermal anchor 1200. Securingthe device 108 relative to the burr hole 112 may be accomplished byclamping the device between opposing retaining surfaces 1234, 1242 ofthe anchor 1200 during implantation as described above. The anchor 1200may be attached to bone (e.g., to the skull) surrounding the burr hole,wherein the device 108 protrudes outwardly through the skin 111. Themethod may further include releasing the device 108 from the anchor 1200by manipulation of the anchor from outside the skin 111. In oneembodiment, releasing the device 108 includes applying a release (e.g.,traction) force to the lock member 1208 protruding outwardly through theskin and removing the lock member from the anchor 1200. By then applyinga force (e.g., traction force) to a portion of the device 108 thatprotrudes outside the skin, the device may be removed entirely from thepatient.

In other embodiments, methods for removing a partially implanted device(such as the catheter 108) extending through the skin-covered burr holeare provided. For example, in one embodiment, the method may includeapplying a release (e.g., traction) force to a lock member (e.g., lockmember 1208) extending through the skin 111, wherein the lock member iscoupled to the subdermal anchor 1200 that is used to immobilize thedevice relative to the burr hole 112. The lock member may be detachedfrom the anchor 1200 and withdrawn through the skin. By then applying aforce (e.g., traction force) to a portion of the device 108 protrudingoutside the skin, the device may be removed entirely from the patientthrough the skin.

FIGS. 21A-21D illustrate an exemplary method of using the anchorassembly 1201 to secure and release the catheter 108 from within theburr hole. After peeling the skin 111 back to expose the skull 113 asshown in FIG. 21A, the burr hole 112 may be formed at a predeterminedlocation in accordance with conventional practices. The base 1202 of theanchor 1200 may then be attached to the skull 113. To assist withattachment of the base, an attachment tool 1295 may be provided. Theattachment tool may interlock with the base 1202 and align the latterwith the burr hole 112. Once aligned, the attachment tool 1295 may alsosupport and align the bone screws 1204 that are used to secure the base1202 to the skull 113.

Once the base is attached to the skull and the tool 1295 is removed, thecatheter 108 may be inserted through the burr hole 112 until the tip islocated at the desired location within the brain. Catheter insertion andpositioning may be accomplished with stereotactic instrumentation (notshown).

While the catheter 108 is supported with the stereotacticinstrumentation, the retainer 1206 (assembled as shown in FIGS. 12 and21 B with the arm in the first or unlocked position and the latch 1212in the first or unlatched position) may be side-loaded around thecatheter 108 as shown in FIG. 21B such that the catheter enters theretainer via the opening 1236. The retainer 1206 (with the lock member1208 attached) may then be set into the base 1202 where it may seat uponthe ledge 1216 as already described herein.

Because the catheter 108 position within the burr hole 112 may varydepending on the targeting procedure utilized, the retainer 1206 ispreferably operable to be rotated about its center axis. That is, theretainer 1206 may be rotated within the base 1202 until the firstretaining surface 1234, at some location along its length, approaches orcontacts the catheter 108. At this point, the latch 1212 may beactivated to release the latch plunger 1262. As described above, thelatch 1212 may be activated by inserting forceps or the like (not shown)into the slot 1284 (see, e.g., FIG. 17) to disengage the tab 1272 fromthe pin 1278 (see, e.g., FIG. 19A). Once released, the latch 1212 maysecure the retainer within the base 1202.

With the retainer 1206 secured, the arm 1210 may be moved from the firstunlocked position (see, e.g., FIG. 17) to the second locked position(see, e.g., FIG. 18). As described above, movement of the arm betweenthe first and second positions may be accomplished by grasping theopenings 1284 and 1286 with forceps and applying a closing force.

Once the catheter 108 is secured, the stereotactic instrumentation maybe removed. After placing the skin flap 111 over the anchor, theincision may then be closed as shown in FIG. 21C. Two openings orpunctures may be formed in the skin flap to permit the passing of thecatheter 108 and the lock member 1208 through the skin. For example, onepossible technique may involve piercing the skin from the outside with aneedle or the like (e.g., Touhy needle), after which the catheter 108(or lock member 1208) may be fed through the needle. The needle may thenbe withdrawn, leaving the catheter 108 (or lock member 1208) extendingthrough the skin opening. The catheter 108 may then be connected to theinfusion pump 106, e.g., via the connector 200 and second tube 102 asillustrated in FIG. 1A. Infusion of the therapeutic substance inaccordance with a desired therapy delivery profile may then commence.

While not illustrated, other components may be utilized to reducebending stress on the catheter 108 during implantation. For example, anelastomer (e.g., silicone rubber) strain relief plate or disk (notshown) may be attached to the surface of the skin (e.g., with adhesiveor dressing). The strain relief plate may include an opening and/or ashaped guide slot through which the catheter 108 may pass. Theopening/slot preferably holds the catheter as it is draped around thescalp and may reduce bending stress on the catheter in the event thatthe catheter is inadvertently pulled at an angle. The plate member mayalso include an opening for the lock member 1208 to pass. In otherembodiments, the entire burr hole site may be dressed or bandaged. Thebandage may include taping of the catheter to the body of the patient soas to provide the desired strain relief.

At, before, or after completion of therapy delivery, the lock member1208 may be removed or detached from the anchor (e.g., removed from theopening 1254 in the body portion 1230) and withdrawn through the skinflap 111 by, for example, application of a release (e.g., traction)force from outside the body 101 as represented by arrow 1297 in FIG.21D. Removal of the lock member 1208 permits the arm 1210 to release itsmechanical engagement force on the catheter 108. Accordingly, thecatheter may be subsequently removed from the patient by the applicationof a force applied to the catheter as represented by arrow 1298.Depending on the size of the lock member 1208 and the catheter 108, theskin punctures 122 remaining after device removal may require suturing.However, in other embodiments, the size of the both components issufficiently small such that no sutures are required.

While described above in terms of passing the catheter 108 and lockmember 1208 through separate openings or punctures, other embodimentsare also possible. For example, the catheter 108 and/or lock member 1208may extend through the skin at the original skin flap incision.Alternatively, the catheter and lock member could be routed through asingle opening or puncture. In still another embodiment, the catheter108 could be tunneled beneath the skin to a remote location.

FIGS. 22A-22B illustrate an anchor assembly 1301 in accordance withanother embodiment of the invention. The anchor assembly 1301 mayinclude an anchor 1300 that is similar to the anchor 1200 describedabove. For example, it may include a base 1302 attachable to the skullwith fasteners 1304, and a retainer 1306 having a movable, e.g.,pivoting, arm 1310. The arm 1310 may include first and second platemembers 1338, 1340 (the lower plate 1340 is illustrated in FIG. 24A) andlocking portions 1360 (see FIG. 23) that are similar in most respects tothe respective components of the anchor 1200 described above. The arm1310 may include an integral pin 1348 formed upon an extension of thelower plate 1340 that engages a corresponding opening in a body or bodyportion 1330 of the retainer 1306 to permit pivotal motion. The arm 1310is illustrated in a first or unlocked position in FIGS. 22A-22B. As withthe anchor assembly 1201, the anchor assembly 1301 may further include alock member 1308 similar in most respects to the lock member 1208already described herein.

The base 1302 may also be similar in most respects to the base 1202. Forexample, it may define a central opening 1314 to receive the retainer1306. An inner edge of base 1302 may have a circumferential groove 1391formed therein. The groove 1391 may be similar in many respects to thegroove 1291 described above. For example, it may define a ledge 1316upon which the retainer may seat. However, unlike the groove 1291, thegroove 1391 may not require teeth (e.g., teeth 1218) as the retainer1306 utilizes a latch of a different configuration.

The latch may, in the illustrated embodiment, be formed by flexible tabs1312 located on a peripheral edge 1332 of the body portion 1330 of theretainer 1306. The tabs 1312 may deflect to permit retainer insertioninto the groove 1391, whereafter the tabs may return to theirundeflected positions. As a result, the retainer 1306 may be biasedagainst the opposite side of the base 1302 as shown in FIG. 22B.Accordingly, like the latch 1212, the tabs 1112 are capable of biasingthe retainer 1306 into the groove 1391 to generally secure the retainerrelative to the base 1302. The spring force of the tabs 1312 ispreferably sufficient to ensure little or no notable rotation betweenthe retainer 1306 and the base 1302.

FIG. 23 is an enlarged perspective view of the anchor 1300 with the arm1310 shown after pivotal movement to a second or locked position tosecure the catheter 108. As with the retainer 1206, the body portion1330 of the retainer 1306 may form a first retaining surface 1334 whilethe arm 1310 forms a second retaining surface 1342. When the arm 1310 isin the first position illustrated in FIG. 22B, the second retainingsurface 1342 may be oblique to the first retaining surface 1334 asalready described above with respect to the first and second retainingsurfaces 1234 and 1242. However, when the arm 1310 is in the secondposition as shown in FIG. 23, the first and second retaining surfaces1334 and 1342 may be generally parallel to mechanically secure thecatheter 108 at most any location along a length of the slot formed bythe two retaining surfaces.

As clearly shown in FIG. 23, the lock portions 1360 are substantiallysimilar to the lock portions 1260 already described above. As a result,a surface of each lock portion 1360 may abut the lock member 1308, e.g.,abut a sleeve provided at a first end 1352 of the lock member, when thearm 1310 is in the second position.

The retainer 1306 may further include openings 1326 to, for example,assist with placing the retainer within the base 1302. The body portion1330 and arm 1310 may also include openings or slots 1328 to assist withmovement of the arm to the second position via forceps or the like.

FIG. 24A is a bottom perspective view of the anchor 1300 showing anoptional cover 1325 that may be placed over the retainer 1306 after thearm 1310 is moved to the second or locked position. The cover 1325 mayprovide a smooth outer surface (as shown in FIG. 24B) to, for example,reduce stress on local tissue (e.g., skin) and limit tissue growth intothe anchor 1300. The cover 1325 may include tabs 1327 configured tosecurely engage one or more of the openings 1326 or slots 1328 in thebody portion 1330.

FIG. 24B illustrates a top perspective view of the anchor 1300 with thecover 1325 installed. As shown, the cover may include a slot to permitside loading of the cover over the catheter 108 after catheterimmobilization. A corresponding slot may be provided to accommodate thelock member 1308. To assist with removal of the cover 1325, a cutout1329 may be provided.

FIGS. 25A-25D illustrate an anchor assembly 1401 in accordance withstill yet another embodiment of the invention. The anchor assembly 1401is similar to the anchor assemblies 1201 and 1301 described above. Forexample, it includes an anchor 1400 having a base 1402 attachable to theskull with fasteners 1404, and a retainer 1406 having a body or bodyportion 1430 and a movable, e.g., pivoting, arm 1410. Like the arm 1310,the arm 1410 may include an integral pin 1448 that engages acorresponding opening in a body portion 1430 of the retainer 1406. Thearm may include a first plate member 1438 and a second plate member 1440(see FIG. 25D) that are similar in most respects to the respectivecomponents of the anchor 1300 described above. The arm 1410 isillustrated in a first or unlocked position in FIG. 25A. The anchorassembly 1401 may also include a lock member 1408 similar to the lockmembers 1208 and 1308 already described herein.

The base 1402 may also be similar in most respects to the bases 1202 and1302. For example, it may define a central opening 1414 to receive theretainer 1406. An inner edge of the base 1402 may further have acircumferential groove 1491 formed therein. The groove 1491 may besimilar in many respects to the groove 1391 described above. Forexample, it may define a ledge 1416 upon which the retainer 1406 mayseat.

The retainer 1406 may include a latch formed by flexible tabs 1412 on aperipheral edge of the body 1430 of the retainer. The tabs 1412 aresubstantially identical to the tabs 1312 already described above.Accordingly, like the latch 1212, the tabs 1412 are capable of biasingthe retainer 1406 into the groove 1491 to generally secure the retainerto the base.

While the retainer 1406 may be secured to the base 1402 in a mannersubstantially identical to the retainer 1306 and base 1302 alreadydescribed herein, movement of the arm 1410 from the first position (FIG.25A) to a second or locked position (FIG. 25B) may be achieved asdescribed below.

The retainer 1406 may incorporate a lock portion configured as a tabmember 1451 slidable within a slot 1453 formed in the body 1430 of theretainer. When the tab member 1451 and the lock member 1408 areretracted within the slot 1453 as shown in FIG. 25A, the arm 1410 ismoved to the first or unlocked position. However, once the catheter 108is located between first and second retaining surfaces 1434 and 1442,the arm 1410 may be moved from the first position (in which the secondretaining surface is oblique to the first retaining surface as alreadydescribed above with respect to the surfaces 1234 and 1242) to thesecond or locked position illustrated in FIG. 25B. In the secondposition, the first and second retaining surfaces 1434 and 1442 aregenerally parallel to one another to secure the catheter 108 at most anylocation along the slot formed by the retaining surfaces.

To move the arm 1410 to the second or locked position, the tab member1451 may be slid within the slot 1453 in the direction indicated in FIG.25B. As the tab member 1451 slides along the slot 1453, it forces afirst end 1452 of the lock member 1408 into contact with a ramped edge1455 of the arm 1410, causing the arm, e.g., the second retainingsurface 1442, to move towards the first retaining surface 1434. Theunderside of the arm 1410 may further include a slot 1421 to accommodatemovement of the lock member as shown in FIG. 25D. When the tab member1451 reaches a location along the slot 1453 corresponding to the arm1410, e.g., second retaining surface 1442, being in the desired lockedposition as shown in FIG. 25B, the tab member may engage a detent (notshown) formed in the body 1430. As a result, the arm 1410 may be securedin the second position of FIG. 25B.

The lock member 108 may be withdrawn, e.g., at therapy completion, fromthe anchor in a manner similar to that described above with respect tothe anchor 1200 and lock member 1208. With the lock member 1408 removedfrom the anchor 1400, the arm 1410 is free to pivot back towards thefirst unlocked position as indicated in FIG. 25C by arrow 1417, therebyreleasing the retention force on the catheter 108. As a result, thecatheter may be withdrawn from the burr hole via the application of atraction force represented by arrow 1419.

FIG. 25D is a bottom perspective view of the anchor 1400 illustrating anexemplary configuration of the arm 1410. As illustrated in this view,the second plate member 1440 may include an extension that forms theintegral pin 1448 about which the arm 1410 pivots. The second platemember 1440 may further define the slot 1421 operable to receive thefirst end 1452 of the lock member 1408. The slot 1421 may transform thelinear movement of the tab member 1451 into pivotal movement of the arm1410. The components of the assembly 1401, as well as of the assembly1301, may be constructed of materials similar to those discussedelsewhere herein with respect to the corresponding components of theassembly 1201.

Anchors and anchor assemblies in accordance with embodiments of thepresent invention may permit anchoring of a device (such as a medicalcatheter or an electrical lead) relative to a portal. While such anchorassemblies may be advantageous in many applications, they may beparticularly useful in medical applications wherein the anchor issubdermally located as may be the case with burr hole access procedures.

Moreover, embodiments of the present invention provide anchor assembliesand methods that permit removal of the device at therapy completionwithout necessitating a separate surgical procedure. For example, theanchor assembly may include a lock member that protrudes outside of theskin such that it is capable of manipulation from outside the patient'sbody. As a result, the lock member may be manipulated and/or removed bythe clinician to release the implanted device at therapy completionwithout surgery. This configuration is not limiting, however, asalternative anchor assemblies may use other mechanical andnon-mechanical lock configurations. For example, the anchor assembly mayutilize a magnetic latch that may be manipulated by a magnetpositionable outside the skin but in close proximity to the anchor.Similarly, a lock that may be released by a remote radio or ultrasonicenergy transmitter could be used.

U.S. patent application No. ______ to Skakoon (attorney docket no.134.02860101), filed on even date herewith, may describe variousexemplary systems and methods for utilizing the components describedherein.

The complete disclosures of the patents, patent applications, patentdocuments, and publications cited in the Background, the DetailedDescription of Exemplary Embodiments, and elsewhere herein areincorporated by reference in their entirety as if each were individuallyincorporated.

Illustrative embodiments of this invention are discussed and referencehas been made to possible variations within the scope of this invention.These and other variations, combinations, and modifications in theinvention will be apparent to those skilled in the art without departingfrom the scope of the invention, and it should be understood that thisinvention is not limited to the illustrative embodiments set forthherein. Accordingly, the invention is to be limited only by the claimsprovided below and equivalents thereof.

1. An implantable catheter for delivering a therapeutic agent to a body,the catheter comprising: an elongate tubular core comprising a distalend and a proximal end, wherein the core defines a lumen extendingbetween the distal and proximal ends, the core comprising a materialselected from the group consisting of silica, quartz, andpolyetheretherketone (PEEK); and an elastomeric jacket surrounding andsecured to an outer surface of the tubular core, the elastomeric jackethaving a radial compliance greater than a radial compliance of thetubular core, and wherein an outer diameter of the elastomeric jacket isabout 4 or more times larger than an outer diameter of the tubular core.2. The catheter of claim 1, wherein the outer diameter of theelastomeric jacket is about 0.8 millimeters to about 1.2 millimeters. 3.The catheter of claim 1, wherein an inner diameter of the tubular coreis about 80 micrometers to about 120 micrometers.
 4. The catheter ofclaim 1, wherein the elastomeric jacket comprises a material selectedfrom the group consisting of polyurethane and silicone.
 5. The catheterof claim 1, wherein the elastomeric jacket comprises a material having adurometer of about 50 to about 60 Shore D.
 6. The catheter of claim 1,wherein the tubular core extends beyond an end of the elastomeric jacketby a distance of about 10 millimeters or more.
 7. The catheter of claim6, further comprising a marker band at a distal end of the elastomericjacket.
 8. The catheter of claim 1, further comprising an intermediatelayer of material between the tubular core and the elastomeric jacket.9. The catheter of claim 8, wherein the intermediate layer comprisespolyimide.
 10. The catheter of claim 1, further comprising one or morestrengthening members surround by, or embedded within, the elastomericjacket.
 11. The catheter of claim 10, wherein the one or morestrengthening members comprise a plurality of braided members helicallywound about a longitudinal length of the catheter.
 12. An implantablecatheter for delivering a therapeutic agent to a body, the cathetercomprising: an elongate tubular core comprising fused silica, thetubular core comprising a distal end, a proximal end, and a tubular bodyforming a lumen spanning between the distal and proximal ends; and anelastomeric jacket comprising polyurethane, the jacket surrounding andsecured to an outer surface of the tubular core, wherein an outerdiameter of the elastomeric jacket is about 4 to about 6 times greaterthan an outer diameter of the tubular core.
 13. The catheter of claim12, wherein the body of the tubular core comprises a radial thickness ofabout 50 micrometers or less.
 14. T]he catheter of claim 12, wherein thelumen of the tubular core defines a lumen diameter of about 100micrometers.
 15. The catheter of claim 12, wherein the elastomericjacket terminates a distance of about 10 millimeters short of the distalend of the tubular core.
 16. The catheter of claim 12, wherein thecatheter comprises one or more locator markings.
 17. The catheter ofclaim 16, wherein the one or more locator markings comprises afluoroscopic marker band located at or near a distal end of theelastomeric jacket.
 18. The catheter of claim 12, wherein theelastomeric jacket comprises two or more abutting tubing segmentsassembled to form the elastomeric jacket.
 19. The catheter of claim 12,further comprising strengthening members surrounded by, or imbeddedwithin, the elastomeric jacket.
 20. The catheter of claim 19, whereinthe strengthening members further comprise a plurality of first braidedmembers helically wound in a first direction about the tubular core, anda plurality of second braided members helically wound in a second,opposite direction about the tubular core.
 21. The catheter of claim 19,wherein the strengthening members comprise elongate fibers comprising amaterial selected from the group consisting of polyester, polyethyleneterepthalate (PET), synthetic polymers, and liquid crystal polymers. 22.The catheter of claim 20, wherein the first and second braided memberscomprise polyethylene terepthalate (PET) fibers.
 23. The catheter ofclaim 12, wherein the elastomeric jacket has a hardness of about 55Shore D.